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Application of Shaobei injection sealing and longitudinal and transverse dilatation scar lysis in rectal stenosis Application of TGF in- ß Mechanism of 1/smads signaling pathway

Application of Shaobei injection sealing and longitudinal and transverse dilatation scar lysis in rectal stenosis Application of TGF in- ß Mechanism of 1/smads signaling pathway

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2022000060
Enrollment
Unknown
Registered
2022-06-26
Start date
2022-08-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorectal stenosis

Interventions

control group:Simple longitudinal and transverse dilatation scar lysis
Treatment group:After the patient fully exposed the tissue at the stenosis, the diluted Shaobei injection (diluted concentration 1:1, i.e. 10ml Shaobei injection and 10ml 0.25% lidocaine hydrochloride

Sponsors

Wangjing hospital, Chinese Academy of traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.1.2 inclusion criteria (1) Patients with iatrogenic anorectal stricture whose anal stenosis ring is less than or equal to 8cm from the anus and who want to undergo surgery, and patients with PPH surgery history, mixed hemorrhoids circumcision history, and sclerosing agent injection history; (2) The stricture ring can be seen through straight second microscope. The mucosal scar contracture at the stricture can be seen. Erosion and ulcer can be found at the stricture. (3) Barium enema examination, colon CT virtual endoscopy examination or Pelvic MRI examination can clearly show the position and range of the stenosis ring; (4) The age range is 18-80 years old; (5) No serious liver, spleen, lung, kidney and serious cardiovascular and cerebrovascular diseases, and can tolerate surgical treatment; (6) Patients without coagulation mechanism disorder did not take anticoagulant drugs in recent half a month; (7) On the premise of informed consent, the patients accepted the implementation process of this study and could complete the follow-up after operation.

Exclusion criteria

Exclusion criteria: 1.1.3 exclusion criteria (1) Patients with neurogenic anorectal stenosis; (2) Patients with allergic constitution; (3) Patients with hypertension or diabetes whose blood pressure or blood glucose is not controlled and balanced; (4) Abnormal coagulation mechanism; (5) Patients with infectious diseases such as tuberculosis, hepatitis B, syphilis and AIDS; (6) Poor general condition and high operation risk; (7) Patients with malignant tumor; (8) The treatment and follow-up period cannot be strictly completed; (9) Combined with other acute perianal diseases such as perianal abscess. 1.1.4 removal and falling off standards (1) Serious adverse reactions occurred and the test could not be continued; (2) Poor compliance, unable to cooperate with treatment and follow-up; (3) It was found that the inclusion criteria were not met.

Design outcomes

Primary

MeasureTime frame
Comparison of stenosis degree and scar thickness;Assessment of stenosis relief;Comparison of anal pain before and after operation;

Countries

China

Contacts

Public ContactFengyuening
fyn20051103@sina.com13716921518

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026